FDA-Device2023-08-09Class II
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Materialise N.V.
Hazard
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Sold states
US Nationwide distribution in the state of KY.
Affected count
1 unit
Manufactured in
Technologielaan 15, N/A, Heverlee, N/A, Belgium
Products
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2023Don't want to check this manually?
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